---
title: Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia
nct_id: NCT00962390
overall_status: COMPLETED
phase: PHASE2
sponsor: Ausio Pharmaceuticals, LLC
study_type: INTERVENTIONAL
primary_condition: Benign Prostatic Hyperplasia
countries: United States, India
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00962390.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00962390"
ct_last_update_post_date: 2017-05-19
last_seen_at: "2026-05-12T06:53:42.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia

**Official Title:** Randomized, Double Blind, Multicenter, Placebo Controlled, Proof of Concept Trial to Assess the Efficacy and Safety of 4 Weeks Treatment With AUS 131 (S Equol) on Benign Prostatic Hyperplasia

**NCT ID:** [NCT00962390](https://clinicaltrials.gov/study/NCT00962390)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 116
- **Lead Sponsor:** Ausio Pharmaceuticals, LLC
- **Conditions:** Benign Prostatic Hyperplasia
- **Start Date:** 2009-06
- **Completion Date:** 2016-01
- **CT.gov Last Update:** 2017-05-19

## Brief Summary

The purpose of this study is to assess the safety and effectiveness of S-equol in men with benign prostatic hyperplasia.

## Detailed Description

The study is a phase 2a, randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of S-equol to placebo in patients with benign prostatic hyperplasia. The study objective is to examine a dose response of 3 dose levels of S equol versus placebo on prostate specific antigen concentrations in patients with benign prostatic hyperplasia. The safety of S-equol will be evaluated during the study.

## Eligibility

- **Minimum age:** 50 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Is male \> 50 years of age at Screening.
* Has a normal digital rectal exam with the exception of prostate enlargement.
* Has suffered from symptoms of BPH for at least the 6 months before Screening.
* Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound.
* Has a serum PSA concentration \> 1.5 ng/mL and ≤ 10 ng/mL at Screening.
* Has an IPSS \> 13 at Screening and Baseline.
* Has a Qmax \> 5 cc/sec and \< 15 cc/sec with a voided volume ≥ 125 cc at Screening (and Baseline, if applicable).

Exclusion Criteria:

* Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug.
* Neurogenic bladder dysfunction.
* Has bladder neck contracture or urethral stricture.
* Has acute or chronic prostatitis or urinary tract infection.
* Has, or has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam or transrectal ultrasound, or has a serum PSA concentration \> 10 ng/mL; patients with a PSA concentration \> 4 ng/mL and ≤ 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator.
* Has a residual void volume \> 250 mL.
* Has any clinically significant unstable condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
* Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma).
* Has a history of smoking more than 5 cigarettes daily within the year before Screening.
* Has resting systolic blood pressure (BP) \> 160 mmHg or \< 90 mmHg, or diastolic BP \> 90 mmHg or \< 60 mmHg at Screening.
* Has bladder stones as detected by ultrasound.
* Has hematuria of unknown etiology.
* Had previous prostate surgery or other invasive treatment for BPH.
* Had prior radiation to the pelvis.
* Has Parkinson's disease or multiple sclerosis.
* Had stroke or myocardial infarction within 5 months before Baseline.
* Has abnormal screening electrocardiogram (ECG) or unstable angina or severe congestive heart failure.
* Has active liver disease renal insufficiency with creatinine \> 1.7 mg/dL, or clinically significant abnormal hemoglobin, white blood cell count, or platelet count.
* Has a history of postural hypotension or has a fall in systolic BP \> 20 mm Hg after 2 minutes in a standing position.
* Received alpha blocker therapy within 28 days before Baseline.
* Received androgens, anti androgens, 5 alpha reductase inhibitors, or luteinizing hormone releasing hormone (LHRH) analogs within 3 months before Baseline.
* Received tricyclic antidepressants or plant extracts (e.g., saw palmetto) within 1 month before Baseline.
* Received sedating antihistamines, sympathomimetics, or anticholinergics within 1 week before Baseline.
* Has initiated new use (i.e., within the past 4 weeks before Screening) or otherwise are not on stable doses of phosphodiesterase 5 inhibitors during the 4 weeks before Screening.
* Has known or suspected history of alcoholism or drug abuse or misuse within the last 5 years.
* Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Clinical Investigator's Brochure for AUS 131 \[S equol\]), to be an unsuitable candidate to receive the study drug.
* Has tested positive on the urine drug screen.
```

## Arms

- **150mg S-equol** (EXPERIMENTAL)
- **50mg S-equol** (EXPERIMENTAL)
- **10 mg S-equol** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **S-equol** (DRUG) — 10mg S-equol 50mg S-equol, \& 150mg S-equol
- **Placebo** (DRUG) — Placebo

## Primary Outcomes

- **Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.** _(time frame: 4 weeks)_ — Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a trend in this proof-of-concept study.

## Secondary Outcomes

- **Change in Prostate Volume From Baseline at Week 4** _(time frame: 4 weeks)_
- **Change in Qmax From Baseline at Week 4** _(time frame: 4 weeks)_
- **Categorical Change in Qmax From Baseline at Week 4** _(time frame: 4 weeks)_
- **Percent Change in Qmax From Baseline at Week 4** _(time frame: 4 weeks)_
- **Change in Void Volume From Baseline at Week 4** _(time frame: 4 weeks)_
- **Change in Post-Void Residual Volume From Baseline at Week 4** _(time frame: 4 weeks)_
- **Change in in Dihydrotestosterone Concentration From Baseline at Week 4** _(time frame: 4 weeks)_
- **Change in Luteinizing Hormone Concentration From Baseline at Week 4** _(time frame: 4 weeks)_
- **Change in Total Testosterone Concentration From Baseline at Week 4** _(time frame: 4 weeks)_
- **Participants Assessment of Nocturia at Week 4** _(time frame: 4 weeks)_
- **Investigators Assessment of Nocturia at Week 4** _(time frame: 4 weeks)_
- **Change in I-PSS Total Score From Baseline at Week 4** _(time frame: 4 weeks)_
- **Change in DAN Prostate Symptom Scale From Baseline at Week 4** _(time frame: 4 weeks)_

## Locations (15)

- Medical Affiliated Research Center, Huntsville, Alabama, United States
- South Florida Medical Research, Aventura, Florida, United States
- Tampa Bay Medical Research, Clearwater, Florida, United States
- Advanced Clinical Research, West Jordon, Utah, United States
- Clinical Research Associates of Tidewater, Norfolk, Virginia, United States
- Samved Hospital, Ahmedabad, India
- M S Ramaiah Memorial Hospital, Bangalore, India
- St. John's Medical College Hospital, Bangalore, India
- G S Medical College and KEM Hospital, Delhi, India
- Indraprastha Apollo Hospital, Delhi, India
- V M Medical College and Safdarjung Hospital, Delhi, India
- SMS Hospital, Jaipur, India
- A J Hospital and Research Center, Mangalore, India
- Inamdar Multispecialty Hospital, Pune, India
- Ruby Hall Clinic, Pune, India

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `locations.g s medical college and kem hospital|delhi||india` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.medical affiliated research center|huntsville|alabama|united states` — added _(2026-05-12)_
- `locations.south florida medical research|aventura|florida|united states` — added _(2026-05-12)_
- `locations.tampa bay medical research|clearwater|florida|united states` — added _(2026-05-12)_
- `locations.advanced clinical research|west jordon|utah|united states` — added _(2026-05-12)_
- `locations.clinical research associates of tidewater|norfolk|virginia|united states` — added _(2026-05-12)_
- `locations.samved hospital|ahmedabad||india` — added _(2026-05-12)_
- `locations.m s ramaiah memorial hospital|bangalore||india` — added _(2026-05-12)_
- `locations.st. john's medical college hospital|bangalore||india` — added _(2026-05-12)_
- `locations.indraprastha apollo hospital|delhi||india` — added _(2026-05-12)_
- `locations.v m medical college and safdarjung hospital|delhi||india` — added _(2026-05-12)_
- `locations.sms hospital|jaipur||india` — added _(2026-05-12)_
- `locations.a j hospital and research center|mangalore||india` — added _(2026-05-12)_
- `locations.inamdar multispecialty hospital|pune||india` — added _(2026-05-12)_
- `locations.ruby hall clinic|pune||india` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00962390*  
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